MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the videoscope image was flashing and sometimes there was no image.The issue was identified during inspection before use for an electronic laparoscopy procedure.There was no delay in the procedure and the patient was not under sedation.The procedure was completed with a similar device.The device was returned and a b30 scope communication error was observed.There were no reports of patient harm associated with the event.

Manufacturer Narrative

A device evaluation confirmed the allegation ¿no image¿.When the slave connector was connected, the screen went blackout and flashed.A b30 scope communication error message was reported and charge-coupled device (ccd) was faulty.It was noted, there was an abnormal adhesive on the light guide (lg) tube.The lg tube and video cable were wrinkled and scratched.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event most likely occurred due to a malfunction of the charged coupled device due to the following handling: a) the system ground wire was not connected b) the video connector was plugged or unplugged while the system was powered on c) dirt or moisture adhered to the video connector contacts the event can be detected/prevented by following the instructions for use which state the following: 1) " do not insert the video connector while the electrical contacts are wet and/or dirty.This may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety." 2) "turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor." olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15756999
• MDR Text Key: 307666917
• Report Number: 9610595-2022-03711
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CV-190 (EVIS EXERA III VIDEO SYSTEM CENTER)